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首页> 外文期刊>European neuropsychopharmacology: the journal of the European College of Neuropsychopharmacology >A meta-analysis of randomized, placebo-controlled trials of vortioxetine for the treatment of major depressive disorder in adults
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A meta-analysis of randomized, placebo-controlled trials of vortioxetine for the treatment of major depressive disorder in adults

机译：伏替西汀治疗成人重大抑郁症的随机，安慰剂对照试验的荟萃分析

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The efficacy and safety of vortioxetine, an antidepressant approved for the treatment of adults with major depressive disorder (MDD), was studied in 11 randomized, double-blind, placebo controlled trials of 6/8 weeks' treatment duration. An aggregated study-level meta-analysis was conducted to estimate the magnitude and dose-relationship of the clinical effect of approved doses of vortioxetine (5-20 mg/day). The primary outcome measure was change from baseline to endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) total score. Differences from placebo were analyzed using mixed model for repeated measurements (MMRM) analysis, with a sensitivity analysis also conducted using last observation carried forward. Secondary outcomes included MADRS single-item scores, response rate (>= 50% reduction in baseline MADRS), remission rate (MADRS <= 10), and Clinical Global Impressions scores. Across the 11 studies, 1824 patients were treated with placebo and 3304 with vortioxetine (5 mg/day: n=1001; 10 mg/day: n=1042; 15 mg/day: n=449; 20 mg/day: n=812). The MMRM meta analysis demonstrated that vortioxetine 5, 10, and 20 mg/day were associated with significant reductions in MADRS total score (Delta-2.27, Delta-3.57, and Delta-4.57, respectively; p <0.01) versus placebo. The effects of 15 mg/day (Delta-2.60; p=0.105) were not significantly different from placebo. Vortioxetine 10 and 20 mg/day were associated with significant reductions in 10 of 10 MADRS single-item scores. Vortioxetine treatment was also associated with significantly higher rates of response and remission and with significant improvements in other depression-related scores versus placebo. This meta-analysis of vortioxetine (5-20 mg/day) in adults with MDD supports the efficacy demonstrated in the individual studies, with treatment effect increasing with dose. (C) 2016 The Authors. Published by Elsevier B.V.
机译：在11个为期6/8周的随机，双盲，安慰剂对照试验中，研究了批准用于治疗重度抑郁症（MDD）成人的抗抑郁药伏替西汀的疗效和安全性。进行了汇总的研究水平荟萃分析，以评估批准剂量的伏替西汀（5-20​​ mg /天）的临床效果的大小和剂量关系。主要结局指标是蒙哥马利-阿斯伯格抑郁量表（MADRS）总分从基线到终点的变化。使用混合模型进行重复测量（MMRM）分析，分析了与安慰剂的差异，并使用最后进行的观察进行了敏感性分析。次要结果包括MADRS单项评分，缓解率（基线MADRS减少> = 50％），缓解率（MADRS <= 10）和临床总体印象评分。在这11项研究中，1824例患者接受了安慰剂治疗，3304例患者接受了vortioxetine治疗（5 mg /天：n = 1001; 10 mg /天：n = 1042; 15 mg /天：n = 449; 20 mg /天：n = 812）。 MMRM荟萃分析表明，与安慰剂相比，伏替西汀5、10和20 mg /天与MADRS总分的显着降低（分别为Delta-2.27，Delta-3.57和Delta-4.57; p <0.01）相关。 15 mg / day（Delta-2.60; p = 0.105）的作用与安慰剂无显着差异。伏替西汀10和20 mg /天与10 MADRS单项评分中的10显着降低有关。与安慰剂相比，伏替西汀治疗还显着提高了缓解和缓解率，并改善了其他与抑郁相关的评分。对患有MDD的成人进行的伏替西汀（5-20​​ mg /天）的荟萃分析支持了各个研究中证实的功效，并且治疗效果随剂量的增加而增加。 （C）2016作者。由Elsevier B.V.发布

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